Source Job

• Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
• Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
• Develop and implement inspection readiness plans and procedures for Health Authority inspections.

Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations.
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan.
• Write and submit reports of investigational site findings and update applicable tracking systems.

Freenome is dedicated to changing the entire landscape of cancer. Freenome is an equal opportunity employer and values diversity.

• Develop and lead the enterprise compliance strategy aligned with institutional growth plans and regulatory expectations.
• Oversee preparation and submission of substantive change applications and institutional reporting requirements.
• Establish enterprise compliance training framework for corporate and campus leaders.

Cotulla Education transforms lives through hands-on, career-focused education. They empower students to achieve their professional dreams in high-demand fields. With experienced faculty providing personalized support, their graduates emerge as future leaders ready to make a significant impact.

• Serve as a subject-matter expert on global clinical and regulatory writing projects
• Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
• Drive development of key clinical documents that align with overall program and submission strategy

Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.

• Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
• Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
• Manages the audit and inspection hosting team.

PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.